Zertane Clinical Results Published in the Journal European Urology
GREENWOOD VILLAGE, Colo., Aug. 30, 2011 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced that the manuscript reporting the results of its phase III clinical trials of Zertane™ for the treatment of the sexual dysfunction, premature ejaculation (PE), was accepted for publication in European Urology.
European Urology has the highest impact factor in the world in the field of urology and is currently read by more than 20,000 urologists across the globe. With an impact factor of 8.843, the journal has become the leading scientific publication in the field http://www.europeanurology.com. Impact factor, a measure reflecting the average number of citations to articles published in science journals, is frequently used as a proxy for the relative importance of a journal within its field. Journals with higher impact factors are deemed to be more important than those with lower ones (Wikipedia).
The manuscript entitled: " A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Orally Disintegrating Tablet for the Treatment of Premature Ejaculation Less than 2 Minutes " authored by Dr. David Bar-Or, MD, the Chief Scientific officer and his colleagues at Ampio Pharmaceuticals, Inc., details the successful efficacy and safety outcomes of the use of Zertane™ in double blinded, placebo controlled phase III trials involving 604 intent to treat patients in 11 countries and 62 sites in Europe. A brief summary of the findings are as follows:
Premature ejaculation (PE) is a widely observed male sexual
dysfunction with an estimated prevalence between 2% and 23% of the
world male population.
Studies have shown that PE is associated with poor satisfaction with sexual intercourse and high levels of ejaculation-related personal distress and interpersonal difficulty.
The median IELT (intravaginal ejaculatory latency time) with the 62mg dosage of Zertane™ increased by 2.4 fold compared to placebo (p<0.001).
All four measures of the PEP (Premature Ejaculation Profile, a validated questionnaire) scores improved significantly compared to placebo (p<0.05) in men. Further, a large percentage of women partners who had poor or very poor satisfaction with their sexual intercourse partner's control over ejaculation and speed of ejaculation reported significantly improved satisfaction with 62mg Zertane™ in at least one category: sexual intercourse (p=0.01), their partner's control over ejaculation (p<0.001) and distress over partner's speed of ejaculation (p=0.02).
The study concludes that on demand Zertane™ provides a new option for managing mild to severe PE and that at the 62 mg very favorable efficacy and safety profiles exist.
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities ("NMEs"). By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio's product development programs.
Ampio's statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties, such as changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Ampio Pharmaceuticals, Inc.
Posted: August 2011